Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century . Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world's premier, most research-intensive biopharmaceutical company. Today, we're doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
Under the direction of the applicable management, the Principal Clinical Data Manager (PCDM) is responsible and accountable, when needed, for ensuring quality and consistent end to end data management deliverables. He/she is also accountable for providing comprehensive technical guidance and design specific recommendations to the Lead Clinical Data Managers (LCDMs). The PCDM is able to work independently or within a team or as a team leader with equal effectiveness. They will interact with staff across multiple Merck sites and serve in the role of mentoring, guiding, and providing project leadership for LCDMs as assigned.
Primary activities include, but are not limited to:
• All required activities outlined in the Lead Clinical Data Manager (LCDM) job description at the discretion and direction of management.
• Helps ensure quality and consistency of data management requirements, specifications and/or deliverables across trials and across therapy areas. This may include, but is not limited to: End to end review of design/data validation specifications consistent with: Protocol requirements, Therapeutic Area (TA) needs and data requirements. Subject Matter Expert (SME) level peer review/quality checks of specification documents and other deliverables.
• Provides process and technical related recommendations and guidance to LCDMs.
• Supports LCDMs via consultancy and teaching by example and review as well as mentoring as needed.
• May be expected to partner with functional area representatives to ensure: appropriate use of database standards. TA/program-level consistency related to database development specifications, data collection guidance and needs, and data validation requirements and tools, including external data in support of the GDO TA lead.
• Keeps abreast of end to end clinical data management processes, procedures, trends and regulations through interaction with stakeholders and experts both within and outside of Merck across the industry.
• Identifies and develops areas for improvement data management processes, standards and tools.
• May lead continuous improvement special projects, or any other data management tasks deemed appropriate by management.
• B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline
• At least 5 years' experience in Pharmaceutical Clinical Data Management
• Expert knowledge of end to end clinical data management
• Experience writing data management tool specifications
• Experience with Oracle's InForm data collection tool
• Process oriented with QC/QA profile and technical expertise
• Demonstrated leadership and project management skills
• Ability to be flexible, to multi-task and work independently
• Strong organizational, communication, and problem-solving skills
• Ability to establish and maintain good working relationships with the different functional areas and work cross functionally as part of a team
• E2E Data Management Standards knowledge
• CDISC/SDTM knowledge or experience
• Experience with Oracle's DMW Tool
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.
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